臺灣博碩士論文加值系統

目的：旨在發展臨床研究護理師(Clinical Research Nursrs, CRN)之關鍵績效指標(Key Performance Indicators, KPIs)，及其重要性、易近性與認同度，並找出影響臨床研究護理師KPI的重要預測因子。

方法：採系統性文獻查證及橫斷式研究法，針對臺灣北中南地區之教學醫院級以上之臨床研究單位、受託研究機構或臨床試驗管理機構及臨床試驗贊助藥廠等，以滾雪球方式蒐集186位臨床試驗研究團隊成員，包括「臨床研究護理人員(N=78)、試驗計畫主持人(N=17)、臨床研究監測員(N=36)與其他臨床研究團隊成員(N=55)」，以專家會議建立問卷效度，並以SPSS17.0及R軟體進行交叉比對分析。

結果：1) 臨床研究團隊成員自覺KPI之重要性、易近性及認同度的總平均及排序和進行排序，並輔以Mann-Whitney U test分析組間差異，選出13項KPI「重要性、易近性及認同度」呈現沒有共識差異之變項；2) 組間差異分析顯示，CRN與試驗計畫主持人群組對KPI「重要性」「易近性」及「認同度」的共識性較高，其中僅5題(8.2%)「認同度」達統計顯著差異水準；CRN與臨床研究監測員群組對KPI「重要性」「易近性」及「認同度」之共識差異程度，分別為21題(34.4%)、21題(34.4%)與30題(49.2%)；CRN與其他研究團隊成員群組的KPI「重要性」「易近性」及「認同度」的共識差異程度為11題(18.0%)、25題(41.0%)與17題(27.9%)，顯示CRN與臨床研究監測員以及其他研究團隊成員對臨床研究護理師KPI之「重要性、易近性及認同度」之看法較無共識；3) 找出重要預測變項分別為「現任職稱為CRN」、「執行Phase IV臨床試驗最多」、「教育程度為碩博士」及「使用電子產品大於等於4項」。以線性多元迴歸方式進行臨床研究護理師KPI認同度之逐步迴歸，總解釋變異量分別為12.9%、14.6%、20.3%、20.8%。

結論：此研究結果可提出臨床研究護理人員績效計算之建議方案、臨床研究護理專業發展以及實務管理層面之參考。

關鍵字：臨床試驗/研究、臨床研究護理、臨床研究護理師、關鍵績效指標、績效評估

Objective: There are 3 aims in this study. First, to identify and develop the Key Performance Indicators (KPIs) of clinical research nurses (CRN). Second, to converge consensus of CRN KPIs in the perpectives of clinical research professional teams in three characteristics of KPIs; importance, accessibility and agreement. Third, to identify important prodicting factors of CRN KPIs.

Method: Systemic literature review and cross sectional study are implemented. Experties in clinical research departments in medical centers around the north, middle and south areas of Taiwan, CROs (Clinical Research Organizations), SMOs (Site Management Organizations) and trial sponsor pharmaceutical companies in Taiwan are enrolled. A total of 186 clinical research team members are enrolled using snowball sampling, which includes CRN (N =78), principle investigators (N =17), Monitors (N =36) and other professionals (N =55). Expert consensus meetings are carried to identify the reliability and validity of the KPIs. The data set was analyzed by statistical software SPSS17.0 and R software for verification.

Results: 1) Thirteen KPI items (of all 61) in all 3 characteristics (importance, accessibility and agreement) showed no statistically difference between clinical research members (Mann-Whitney U test). 2) Inter-group analysis showed that CRN group shares the highest consensus with investigator group on KPI "importance", "accessibility" and "agreement", and only 5 (8.2%) KPI items in agreement are statistically different. The CRN group and the monitor group have different perspecitves in KPI "importance" 21 items (34.4%), "accessibility" 21 items (34.4%), and "agreement" 30 items (49.2%). The CRN group and the other group showed different perspecitves in KPI importance, accessibility, agreement in 11 items (18.0%), 25 items (41.0%) and 17 items (27.9%) respectively. Our data indicate that CRN group share less KPIs consensus with the monitor group and other professionals group. 3) Four regression analysis models are established to find the important predictors of KPI agreement; "job title as CRN" and "experience of more phase IV trials" are negative predictors for KPI agreement, "Education in master or PhD" and "Use of electronic products is greater than or equal to 4" are positive predictors. Stepwise linear regression and F test were performed and 12.9%, 14.6%, 20.3%, 20.8% of the variance of the four models could be explained.

Conclusion: This study proposes a CRN performance review proposal. This study can be applied to the development of clinical research nursing profesional and practical management system.

Key words: clinical trials/research, clinical research nursing, clinical research nurses, CRNs, key performance indicators, KPIs, performance evaluation

口試委員會審定書 i
誌謝 ii
中文摘要 iii
英文摘要 iv
目錄 vi
圖目錄 ix
表目錄 x
第一章 緒論 1
第一節 研究背景、動機與重要性 1
第二節 研究目的 4
第三節 研究問題 5
第四節 名詞定義 6
第二章 文獻查證探討 9
第一節 國內、外臨床研究護理師之發展現況與實務執行管理 9
第二節 關鍵績效指標（KPI）之相關論述 22
第三節 關鍵績效指標（KPI）於臨床研究專業之應用 27
第四節 臨床研究護理師質性與量性之關鍵績效指標（KPI） 29
第三章 研究方法 121
第一節 研究架構與研究假設 121
第二節 研究設計 123
第三節 研究選樣對象與場所 124
第四節 研究工具 127
第五節 資料收集過程 131
第六節 資料統計與分析 133
第七節 研究倫理考量 136
第四章 研究結果 137
第一節 研究對象基本屬性與其臨床研究相關工作經驗分析 138
第二節 研究團隊成員對研究護理師關鍵績效指標之重要性、易近性及認同度之分析 152
第三節 臨床研究團隊對各項關鍵績效指標及評核重點認同的共識程度分析 195
第四節 臨床研究團隊對關鍵績效指標與臨床研究護理師之認同差異性分析 227
第五節 運用臨床研究團隊成員之KPI排序探索最適切KPI指標 248
第六節 影響臨床研究護理師關鍵績效指標認同度之重要影響因素 258
第五章 討論 265
第一節 那些原因造成臨床研究護理人員的KPI描述性分析之差異 265
第二節 從管理者視角評析KPI之適切性 267
第三節 對臨床研究護理人員KPI之管理實務提出可應用之建議方案 269
第六章 結論與建議 272
第一節 結論 272
第二節 護理專業與產業界之應用 274
第三節 研究限制與建議 276
參考文獻 277
中文文獻 277
英文文獻 278
附錄 289
附錄一 臨床研究護理師自覺發展的KPI問卷初稿 289
附錄二 專家會議(一)名單 303
附錄三 專家建議之問卷修改內容 304
附錄四 從管理實務經驗發展臨床研究護理師績效指標—潛在量性與質性KPIs選項之結構性問卷 316
附錄五 倫理委員會審查通過核准函 326
附錄六 倫理委員會審查變更案通過核准函 329
附錄七 專家會議(二)名單 330

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